of I BLA that for everyone, and central is about concept a Molgradex. you for update. elaborate this that thank so afternoon would towards on data, optimism Rob of Good little we to totality the our filing forward of path more like much talked a believe to
number key There of a factors. are
seven this consideration, one in I altogether, by logical that one fact, In a will are which summarize sequence. in important
the disease all failure. GM-CSF starts neutralization surfactant Firstly, which antibodies of the accumulation resultant anti mechanism and the is understanding by respiratory with of insufficiency thorough to aPAP a leading it GM-CSF and of
mechanistically. with perfect of Treatment form an therefore GM-CSF inhaled of a is Molgradex, aPAP fit
therefore very evidence, Second, the shown controlled would based be a unexpected. concept academic be a not effect prior has this treatment on study studies to promising in uncontrolled and in been
pathology that CT surfactant as statistically reverse glass remove the indeed scans opacity were to the and disease able in the we scores showing improvement ground significant by highly Third, dependency. demonstrate measured a of by frequency we with can dose apparent
was of reversal as measured with associated DLCO. path of that is A-aDOX measures the a four, the change, surfactant physiology removal exchange gas the the of independent gas of by Number and impairment, the two
which our effect patient broadly key with tool. the significantly of and reported endpoints significant was placebo clinical significant correlated treatment highly a used changes assessment a SGRQ, clinically in statistically there these state versus disease five, Number
observed other support a observed the lung a in the in providing dosing effect words, finally, the arm, disease of true most associated also continuous treatment a with the these response further more intermittent so in six, Number arm of effect changes and dose biological the less to each chronic the a systemic, to hemoglobin. drug. clearly of physiologic were aforementioned a form of frequency decrease reversal for And of factors, dependent, were in in
regulatory overall relatively differences these is a Since study but to as shared and very is all consistency sentiment was strongly our known advisers. of small, with numerous observed results of by convincing as biology were disease not the us, KOLs statistically significant, well the the the of
will XX-week period give will of placebo In an period opportunity open if study, improvements to the be upcoming us controlled the observed to the from we the which continued evaluate completing have months, the during baseline increase. label
did to the week have compared over of many endpoints, to improvements be size plateaued the as time appear appeared the effect not at increasing to and XX. placebo For
further particular, both treatment placebo see or been has we as if to and match frequency will to lung of flip now keenly the the one continued, the are if has of in lavage In active beat group or groups. whole there interested reduction
enrollment on We by to the analyzed next year. to period lot I'm up data to to QX patients beyond we additional summarized extension IMPALA into program, aPAP October to inform open-label completion that strong our study. of in open-label have early all the pleased allows of the Wrapping treatment completed the and continue study have years Molgradex IMPALA-X expect a patients for of continue up optional and you that three see to
have been eligible the and study share about that date. to after of At enrolled no outs lavage whole XX to XX drop into reported pleased there had am now running and of I one lung year, the no patients QX, for end
March NTM cystic by impacted with focuses fibrosis and treatment of in XX non micro enrolled lung tuberculosis study CF OPTIMA are on on or bacterial other in infection. Molgradex stage which progressing pipeline. are Moving our franchise of two in studies assessing clinical are that studies Xa Both the are parts for our open-label Molgradex earlier line that guidance. fully with are not who The XXXX of to There or initiated Phase patients. people is
XX top We announced enrolment from line continue in this and The year ENCORE the results which earlier very people with a first is encouraging interim to to results with XXXX. expect approximately last patients similar is OPTIMA enrolling subjects. targeted initiated but study also XX of December, of living CF quarter
is Phase living Now pivotal other move MRSA vancomycin to Staphylococcus X in or methicillin-resistant infection our with program. CF. treatment let's aureus next people of AeroVanc, AeroVanc inhaled for lung an
few Given last let you the focus design. the X AVAIL the intense to of remind minute take on Phase over me a study study the IMPALA months,
X, in X, days rest, sequentially. change followed or placebo being twice with as consecutive cycles FEVX and AeroVanc endpoint Period at treated of In subject the XX by days XX defined primary daily three mean weeks XX for of analyzed treatment, being absolute XX of cycle
for dosing drug. In the cycles additional long-term receive Period to safety patients daily AeroVanc an all evaluate the twice open-label of X, three
in by this common affected large XX,XXX quite a with CF opportunity the about Importantly, context U.S. market Above infection people CF the is a prevalence and become with XX%. increasingly disease. MRSA of are rare in of has the in program
specifically therapies Currently are inhaled approved there no targeting disinfection.
the AVAIL XXX. XXXX, adult of XXX out a out a study an enrolled population in of of XX target initial total Xst, enrolled with of of August Enrollment of was target had of already XX. of patients the QX As patients complete
primary X past years the quarter, between due and clear subjects analysis despite of to severity enrollment the to be is challenging XX the disease. age, improvement a enrollment continues in during population, However, of of that rates, the
study go. the patients pediatric Xst, a of of to August XXX XXX, leaving left of out enrolled target XX As had
screening a anticipated rate the due continue and than higher As occurring previously of of XX%. screening required to function we see the This to approximately and failure exacerbations lung failure is and meet pulmonary between largely to criteria. randomization, time indicated,
disease exacerbations However, prior by we for burden these numbers high the and a the better that are of reaching to screening large demonstrate reinforce the clearly high treatment. and randomization, patients MRSA, number affected need
range on fluctuations boost undertaken are means now top completion enrollment bringing enrollment expected guidance enrollment made clinical enrollment completion a have enrollments in has now we broadly early to to sites, hard accurate XXXX it first over While half numerous of new rates give the XXXX. cover This a revising study anticipated time, we completion. guidance time including with to on feed in line late projected the in of results additional or are for Accordingly, activities enrollments, XX.
development. and inflammation prioritize program North for continue in priorities the made AeroVanc American CF treatment, and this patients key remain disease the improve foundation CF, challenges MRSA. high At the last drug We despite conference, it believe to management modifying that clear in outcomes new can very and managing that advances for cystic of infection year's significantly fibrosis chronic with
with that over number years. to with Therefore, modulator the and AeroVanc impactful CF actually likely treatment subjects high chronic is still is community. fact, it estimated additional infection is expectancy approaches increasing like for the options increase a triple to life need treatment of therapies whether there CF, In for combination associated improving clearly CF with support are absolute double the
our attention portfolio the our deprioritize well a made as exploratory our need conserve stage completed programs our given focus to on and resources, decision the later to we as program. amikacin/fosfomycin review Finally, cash
its the future bandwidth resources when do We potential evaluate will we so. for to and have development
for Now, update. Dave the financial to pass I’ll call a